Contactless Vital Signs Measurement Study (CVMS)

Last updated: June 3, 2023
Sponsor: Melbourne Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device

Clinical Study ID

NCT05886686
RMH89542
  • Ages 18-110
  • All Genders

Study Summary

This study asks the question - Can vital signs be accurately measured via a contactless device and can this be independently done by inpatients in their homes? Primary objectives are to validate the accuracy of contactless vital sign measurements in comparison with vital signs measurements of heart rate, oxygen saturation, temperature using standard ward equipment (the reference standard).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Admitted inpatients within two hospital wards
  • Patients expected to remain admitted within the two wards over 7 days of the study foravailability of their vital sign measurements
  • technological capability to utilise the device's companion app, as evidenced byownership and utilisation of a 'smart' device (eg smartphone)

Exclusion

Exclusion Criteria:

  • Cognitive disability impeding participants' ability to independently conduct vitalsign measurements
  • Clinical instability impeding participants' ability to independently conduct vitalsign measurements
  • Physical concerns (e.g. manual dexterity) impeding participants' ability toindependently conduct vital sign measurements
  • Environmental and technical issues such as lack of home Wi-Fi system, location of homein a 'Wi-Fi black spot', or unsafe home environments, that impede participants'ability to independently conduct vital sign measurements

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
Phase:
Study Start date:
April 05, 2023
Estimated Completion Date:
September 30, 2023

Study Description

'Vital signs' such as heart rate (HR), temperature and peripheral blood oxygen saturation (SpO2) are routinely measured four times a day amongst hospitalised patients. However, this frequency of monitoring is unable to be replicated amongst patients in the RMH@Home Acute program. Also known as Hospital In The Home (HITH), RMH@Home Acute nurses and doctors deliver treatments to patients at home in substitution for a hospital admission. Home-based reviews are conducted one to two times daily, with more frequent reviews limited by travelling times and geographical constraints.

Accordingly, this study aims to investigate the accuracy and user-friendliness of new contactless technology to measure patients 'vital signs', paving the way towards enabling home-based patients to independently measure their vital signs during their admission. Besides enabling increased frequency of routine monitoring, this technology can also be applied to improve ad hoc assessments when patients report clinical concerns by enabling vital signs to be remotely measured by patients and/or their carers whilst clinicians travel to their homes to deliver treatment. Results from publication of this study will add to lexicon of knowledge regarding the utility of remote monitoring devices in monitoring and detecting clinical deterioration amongst hospitalized patients at home.

In this two-stage study, participants' vital signs obtained by the new contactless sensor are first compared with standard vital sign measurements obtained by nursing staff on the hospital ward. Should the sensor be found to obtain similar measurements thus indicating accuracy and feasibility of use amongst hospital patients, the second stage of this study involves investigating the feasibility of participants utilising these devices to measure their vital signs in the home-setting.

Connect with a study center

  • Royal Melbourne Hospital

    Melbourne, Victoria
    Australia

    Active - Recruiting

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